KR20210084518A - Systems and methods for the controlled transfer of medical devices to a patient's body - Google Patents

Abstract

An endovascular delivery system for deploying a therapeutic device, such as a stent, in a controlled and reliable manner is supported by a lockable balloon catheter having a locking mechanism configured to engage in vivo to a delivery component, such as a guidewire. The engageable balloon catheter may be controllably switched between engaging and disengaging modes of operation by inflation/deflation of the balloon of the engageable balloon catheter. In a fastening mode of operation, the engageable balloon catheter facilitates transport of the therapeutic element along the transport part to the target site while improving stability of the transport part, particularly near the target site.

Description

Systems and methods for the controlled transfer of medical devices to a patient's body

The present invention relates to medical devices, and more particularly to human (or animal), for example, vasculature (such as blood vessels), also bile ducts, and renal ureteric ducts. It relates to a minimally invasive device used for treatment inside the internal passages of the body.

The present invention also relates to a delivery system for percutaneous coronary intervention, for example for intravascular balloon angioplasty.

The present invention also provides, for example, a therapeutic device such as a stent using a balloon catheter that can be fastened in vivo to a delivery component such as a guidewire. ) for medical devices designed for intravascular deployment (direct to).

In general terms, the present invention provides a therapeutic element such as a stent to the internal passages of the patient's body (eg, intravascular, or other internal tube-like structures of the patient), at the lesion site (lesion). The number of fixture replacements required to place a transfer component, such as a guidewire, within a vessel (e.g., a patient's vessel, etc.) at the lesion site inside the internal tubular structure while securing it within the vessel during advancement of the treatment member to the site. A system and method for deploying in a controlled and robust manner that can reduce

The system of the present invention also targets a balloon catheter having a locking mechanism to be inserted into a blood vessel under treatment, for example, to be fastened in vivo to a transfer part such as a guidewire, the fastened balloon The catheter facilitates the transport of additional components (such as the treatment device delivery catheter) to the target site for treatment along the transfer component (guidewire) while improving the stability of the transfer component when it is near the target site. .

The present invention also provides a guide near a target site to improve stability of the guidewire in vivo by minimizing movement of the distal end of the intravascular guidewire and facilitating transport of additional intravascular components along the guidewire. An endovascular delivery system supported by a balloon catheter with a mechanism for anchoring and stabilizing a wire is intended.

The present invention also provides an endovascular kink resistant delivery system that is reinforced with an external rail (or buddy system) to facilitate advancement of additional endovascular devices, such as stents, into the lesion. target

In addition, the present invention disrupts the lesion by transferring the balloon catheter to the lesion in the blood vessel on the guidewire and inflating the balloon of the balloon catheter with a conventional balloon inflation device to dilate the blood vessel. . The balloon is then deflated and moved near the lesion to inflate the balloon, thereby securing the balloon catheter to the guidewire. One or more additional intravascular components are then transferred to the lesion while the balloon catheter is secured to the guidewire to anchor and stabilize the guidewire within the vessel.

Ischemic cardiovascular syndromes affect blood flow by narrowing, weakening, or blocking blood vessels, often resulting in a buildup of material inside the blood vessels (referred to herein as lesions). ). Ischemic cardiovascular syndromes include coronary vascular syndromes, commonly referred to as coronary artery disease (CAD), generally involving blood vessels to and/or returning from the heart, as well as commonly referred to as peripheral arterial disease (CAD). peripheral vascular syndrome involving blood vessels to and/or returning from the heart or brain, referred to as peripheral artery disease (PAD).

Endovascular treatment of ischemic cardiovascular syndrome involves the percutaneous introduction of a catheter, for example, through a blood vessel, such as the femoral artery, and thus less traumatic to the patient than an open surgical approach. to allow access to vascular lesions through

Percutaneous transcutaneous of coronary and peripheral arteries (PTCA and PTA, respectively) Percutaneous transluminal angioplasty is used for ischemic cardiovascular syndromes (eg chronic and acute coronary ischemic syndromes) and ischemic cardiovascular syndromes (claudication and critical lower extremity ischemia). It is widely accepted as the revascularization surgery of choice for patients with peripheral ischemic syndromes (such as chronic lower extremity ischemia, including limb ischemia).

However, the use of conventional percutaneous treatment may be limited by re-occlusion or restenosis. This may be due to the active proliferation of smooth muscle cells growing to occlude the treated vascular segment, the progression of atherosclerotic plaques, and negative reconstitution of the treated segment leading to recurrence of symptoms. Restenosis or restenosis may require potential re-intervention for further treatment.

Various auxiliary means for angioplasty are trying to reduce restenosis through various techniques. These techniques may include the use of bare metal and nitinol stents in conjunction with extractional, rotational, orbital, or laser atherectomy, and more recently, drug-releasing stents. (drug eluting stents; DES) have begun to be used to treat/prevent restenosis. This technique has been shown to significantly reduce coronary restenosis compared to angioplasty or bare metal stents.

In the peripheral arteries, the use of nanitinol stents has been shown to be superior to balloon angioplasty alone, particularly for the "default" percutaneous treatment of chronic lower extremity ischemic syndrome with complex disease patterns involving the femoropopliteal artery emerged as a strategy.

Stents have been routinely used to treat occlusive vascular disease. For example, U.S. Pat. No. 5,135,536 to Hillstead and U.S. Pat. No. 5,314,444 to Gianturco disclose stents having expandable wire tubes with reduced diameters for transluminal placement. Once the stent is placed within the vessel, a balloon catheter is used to dilate the stunt to support and reinforce the entire circumference of the vessel. Such prior art stents typically have high radial strength to resist collapse due to vascular disease.

In the conventional procedure of percutaneous transluminal angioplasty followed by stent transfer, the guidewire is first percutaneously advanced to the lesion inside the blood vessel. An angioplasty balloon catheter is then advanced over the guidewire to the lesion. Angioplasty balloon catheters may be advanced over-the-wire (“OTW”) or rapid exchange (“RX”) fashion. Once in place, the balloon inflates to expand the blood flow channel inside the blood vessel at the lesion site.

In a subsequent step, the angioplasty balloon is removed from the vessel while the guidewire remains in place, and a stent delivery balloon catheter is advanced onto the lesion on the guidewire for stent delivery.

Disadvantages of the procedure performed in the prior art are the limited safety and difficulty of advancing the stent delivery balloon catheter across the lesion, even after angioplasty, since the guidewire does not constitute a sufficiently stable structure for the advancement of the catheter in the blood vessel. For example, a free distal tip of a guidewire can move uncontrollably inside a blood vessel. Uncontrollable vocalization of the distal end of the guidewire may cause the guidewire to retract into the guidewire lumen of the stent delivery balloon catheter during advancement within the vessel. This can occur when the blood vessels are tortuous and diffusely deceased and severely hardened (calcify) or lack of support of the catheter guide. If the surgeon attempts to advance the stent delivery balloon catheter along the unstable remote free end of the guidewire, there is a risk of vessel damage, including dissection. Accordingly, it is often necessary for the surgeon to remove the stent delivery balloon catheter and reintroduce the angioplasty balloon catheter onto the guidewire to perform an additional angioplasty procedure. This exposes additional risks to patient health, reduces the efficiency of the procedure, can be abandoned without installation of a treatment device, and is very costly.

The demand for endovascular therapy is increasing dramatically, especially with the growing population of patients with conditions associated with significant vascular wall hardening, such as those with diabetes and/or chronic kidney disease. There are patients for whom current treatment is insufficient and/or ineffective. There is therefore a need for improved endovascular techniques that enable intravascular placement of therapeutic devices, such as stents, in a controlled and reliable manner.

Accordingly, it is an object of the present invention to introduce a therapeutic element (such as a stent) to a tubular internal structure of the patient's body, such as, for example, intravascular or other passageways such as the bile duct or renal ureter, during advancement of the therapeutic element to the lesion site. Placement in a controlled and reliable manner that allows efficient anchoring of transfer members, such as guidewires, within the vessel while supporting the reduction of the number of equipment replacements required to place the therapeutic device near the lesion site within the vessel. To provide a system and method for

Another object of the present invention is to releasably fix the balloon catheter to a transfer part such as a guide wire in vivo, especially while improving the stability of the guide wire inside the blood vessel near the lesion site. The balloon catheter provides a fastening mechanism that facilitates the transfer of additional components, such as, for example, a therapeutic device delivery catheter, along the guidewire to the lesion site.

It is a further object of the present invention to provide sufficient rigidity and stability of the guidewire in the vicinity of the target (lesion) site inside the blood vessel to benefit the transfer of a treatment member, such as a stent, to the lesion site, for example. An object of the present invention is to provide an endovascular delivery system that prevents uncontrollable movement of the stage.

Another object of the present invention is to reduce the displacement of the guide wire inside the blood vessel by facilitating the transfer of additional intravascular components along the guide wire by fixing and stabilizing the guide wire in the vicinity of the target site inside the blood vessel. SUMMARY OF THE INVENTION To provide an endovascular delivery system using a lockable balloon catheter having a locking furniture that operates to achieve improved in vivo stability.

Another object of the present invention is to transfer the balloon catheter to the lesion in the blood vessel on the guidewire, and to pre-dilate the blood vessel by inflating the balloon with a conventional balloon inflation system (calcified embolism (calcified embolism ( calcified plaque), then deflate the balloon to move the balloon near the lesion site, and re-inflate the balloon to fasten the balloon to the guide wire. It is to provide a method of using the present invention (subject) balloon catheter controllably fastenable to a wire. One or more additional intravascular components may then be transferred to the lesion site while the balloon catheter of the present invention is fastened to a guidewire that is anchored and stable inside the vessel during the procedure.

It is also an object of the present invention that the axis of the catheter is reinforced with an additional support and/or rail mechanism for advancement of the endovascular component along the guidewire when the balloon is in a locked or unlocked configuration. To provide an anti-distortion endovascular delivery system.

According to one aspect of the subject system, there is provided an intravascular system that reliably advances a stent to a lesion inside a blood vessel (or bile duct or ureter) of a patient on a guidewire. is provided The system of the present invention comprises an elongated catheter shaft having a proximal region and a distal region, and an inflation lumen extending between the proximal and distal regions within the elongated catheter shaft; , a rapid-exchange (RX) port formed on the interior of the elongated catheter shaft and a guidewire lumen extending between the distal tip of the balloon catheter.

A balloon is attached to the remote region of the long catheter shaft. The proximal end of the balloon is spaced a short distance from the rapid change (RX) port of about 5 mm-30 mm. This placement achieves stability as the stent is advanced along the guidewire to the site of the lesion inside the vessel proximate to the rapid replacement port while the balloon remains inside the vessel.

A locking portion of the elongate catheter shaft is located inside the balloon and extends between the proximal and distal ends of the balloon. The engagement of the long catheter shaft moves from a release mode of operation in the balloon (when the diameter of the guidewire lumen is sized to allow for a slidable displacement with respect to a guidewire positioned within the guidewire lumen) to an engagement mode of operation in the balloon. It may be configured to transition. In the fastening mode of operation, the fastening of the long catheter shaft is squeezed within the balloon to reduce the diameter of the guidewire lumen so that the walls of the guidewire lumen are in contiguous contact with the guidewire to engage and squeeze the guidewire around the guidewire. is "anchor" within the guidewire lumen.

The engagement portion of the elongated catheter shaft may include a flexible material that facilitates compression with the walls of the guidewire wall of the guidewire. The flexible material may include a braided material. The knitted material may be coated with a polymer so that the engagement portion of the long catheter shaft inside the balloon is fluid impermeable.

The balloon catheter may have a plurality of radiopaque markers disposed along an elongate catheter axis. The radiopaque markers may be positioned adjacent to the quick change port.

According to another aspect of the system of the present invention, a method is provided for reliably advancing an endovascular delivery system to a lesion inside a patient's blood vessel on a guide wire along a balloon axis. This method involves the following steps:

It includes the step of manufacturing a balloon catheter that can be fastened to the guide wire inside the blood vessel. The engageable balloon catheter has a proximal region, a remote region, a first lumen extending between the proximal region and the remote region, and a first lumen extending distally from a rapid exchange (RX) port within the elongated catheter shaft. 2 includes a long catheter shaft with a lumen.

The balloon is attached to a long catheter shaft in a remote area so that the proximal end of the balloon is spaced a short distance of approximately 5 mm - 30 mm from the rapid replacement port to proximate the metal replacement port while the balloon is inflated inside the body lumen. A stable advancement on the transfer component (guidewire) of the treatment member (stent) to the target site within the body cavity is achieved. The long catheter shaft is from a release mode of operation inside the balloon (when the diameter of the first lumen is sized to allow sliding of the transfer part (guidewire) therein) to an engagement mode of operation (the long catheter shaft is compressed inside the balloon). and the diameter of the second lumen is in contact with the circumference of the conveying part (guide wire), so that the conveying part (guide wire) is converted into a second lumen when it is fixed inside the second lumen according to the pressurization of the balloon.

The method of the present invention comprises the following steps:

Transferring the fastenable balloon catheter to the lesion inside the blood vessel on the guide wire;

Inflating the balloon of the fastenable balloon catheter to expand the blood vessel and destroy the lesion;

deflating the balloon;

moving the deflated balloon past the lesion inside the blood vessel on the balloon catheter; and

The step of fastening the balloon catheter to the guidewire by re-inflating the balloon is further provided. Inflation of the balloon clamps the balloon catheter to the guidewire by pressing the walls of the second lumen inside the vessel around the guidewire to lock the guidewire in place.

The method of the present invention leads to the step of transferring another catheter (for example, a stent catheter) to the lesion site on the guidewire while the fastenable balloon catheter is fastened to the guidewire to fix and stabilize the guidewire inside the blood vessel.

The systems and methods of the present invention reduce the number of equipment changes required to place a treatment device at the marginal site while securing the transfer component within the vessel while advancing the treatment catheter to the lesion site.

These and other objects and advantages of the system and method of the present invention will become more apparent to those of ordinary skill in the art upon reading the detailed description of the present invention in conjunction with the (attached) drawings.
1 shows an exemplary embodiment of a fastenable balloon catheter of the present invention;
FIG. 2 shows an endovascular delivery system of the present invention for use with the balloon catheter shown in FIG. 1 including a therapeutic device delivery catheter and a sheath and guidewire; FIG.
3A, 3B, and 3C are schematic views of a remote area of one embodiment of the engageable balloon catheter of the present invention shown in FIG. 1 , in an unlocked state ( FIG. 3A ) and an engaged state 3B , while FIG. 3C is an operation of FIG. A longitudinal cross-sectional view of the engageable balloon catheter of the present invention in an engagement mode;
Figures 4a and 4b are configured to have a flexible material at the fastening portion of the catheter of the present invention inside the chungseon to promote the operation of the catheter that can be fastened according to the present invention in the release mode of operation (Fig. 4a) and the fastening mode of operation (Fig. 4b) Schematic views of the remote area of another embodiment of the inventive engageable balloon catheter;
4C-4D schematically show a wire-type anti-distortion mechanism ( FIG. 4C ) or an alternative anti-distortion mechanism attached to the RX port, embedded in the remote region of the long axis between the RX port and the balloon; and
5A-5L are diagrams showing exemplary steps of an endovascular transfer procedure in which a therapeutic device is transferred to a target site inside a blood vessel using the fastenable balloon catheter of the present invention.

1-4D and 5A-5L show inside a tube-like internal structure of a patient's body (such as a blood vessel (body lumen), or bile duct and ureteric duct). A system for deploying a therapeutic device is shown.The principles of the system and method of the present invention can be applied to therapeutic procedures associated with other internal passageways (tubular structures) within the patient's body, but the present invention follows. The description of the system design and operation will focus on intravascular applications.

The system of the present invention comprises a balloon catheter that can be locked to a delivery component, for example, a guidewire, which is positioned inside a blood vessel in situ in vivo. . Following the fastening of the fastenable balloon catheter to the guidewire, the fastened balloon catheter stably anchors the guidewire at a position adjacent to the target site in the blood vessel while other methods for transporting treatment devices such as stents A catheter may be advanced over the guidewire to a target site in the blood vessel.

The system of the present invention treats peripheral artery disease (PAD) along with ischemic cardiovascular syndrome, including coronary vascular syndrome, sometimes also referred to as coronary artery disease (CAD). particularly for conditions associated with vessel wall tortuosity, diffuse disease, calcification, or poor intraocular catheter support during peripheral vascular syndrome, referred to as Fits well.

1 , the endovascular delivery system 1 of the present invention comprises an elongated shaft extending between a proximal region 14 and a distal region 16 of a balloon catheter 10 ; 12) is provided with a balloon catheter (10) comprising a. The balloon 18 is mounted on a remote area 16 of the long axis 12 . The elongated shaft 12 has a portion 17 that extends into the balloon 18 (which will be referred to as a locking portion 17 hereinafter in this specification).

The proximal end 14 of the elongate shaft 12 preferably includes a handle 20 to assist the operator in manipulating the engageable balloon catheter 10 .

The balloon inflation port 22 at the proximal end 22 of the proximal region 14 has an inflation lumen 24 extending into the elongate axis 12 as shown in FIGS. 3A-3C . It is connected to the interior 19 of the balloon 18 via.

The handle 20 and the balloon inflation port 22 will be members used in conventional balloon catheters, and thus will not be described in more detail in this specification. Like the proximal region 14 of the engageable balloon catheter, the handle 20 and balloon inflation port 22 may be constructed of materials commonly used in endovascular catheters, such as, for example, polyethylene and/or polyterephthalate. .

The engageable balloon catheter 10 is preferably of a length and diameter suitable for use in the cardiovascular or peripheral vessels being treated. The balloon catheter 10 may have a length ranging from 60 cm to 180 cm and a diameter ranging from 1.0 mm to 60 mm.

Balloon 18 may be in a closed (retracted) configuration (shown in FIGS. 3A and 4A, 4C, 5B, 5D - 5E, and 5H - 5I) or (Figures 1 - 2, 3B - 3C, 4B, It can assume an expanded (expanded) state (shown in 4d, 5c, and 5f - 5g). 1, balloon 18 is shown in an expanded state suitable for dilating blood vessels. The balloon 18 may be made of a noncompliant material (such as polyethylene), a semi-compliant material (such as polyterephthalate), or a flexible (compliant) material (such as nylon).

The balloon 18 may be sized and shaped for the intended treatment and for insertion into a vessel suitable for the body cavity (vessel) being treated. For example, the length of the balloon 18 may range from 1 cm to 20 cm. The balloon 18 to be inserted into a smaller body cavity (such as a coronary vessel) has a diameter of about 1.0 mm - 6.0 mm in the expanded state. Alternatively, a balloon to be inserted into a larger body cavity (such as a peripheral blood vessel) may have a diameter of about 4 mm - 10 mm. Also, if the catheter 10 is used for treatment involving the thoracic or abdominal aorta, the balloon 18 may have a diameter of about 1 cm to 6 cm.

The balloon 18 is preferably attached to the fastener 17 of the elongate shaft 12 by thermal bonds, glue welds, or other suitable methods.

Balloon 18 is configured to expand when pressurized by introducing fluid (air) through balloon inflation port 22 under control of balloon inflation system 25 .

The balloon inflation system 25 is operatively connected in a fluid-tight manner to the balloon inflation port 22 to and from the balloon 18 (eg saline, iodinated contrast agent). contrast media), or air, etc.) to support the passage of the expansion fluid 27 .

The balloon inflation system 25 schematically illustrated in FIG. 1 may be a manual or automatic system. In a preferred automatic embodiment, the balloon inflation system 25 may include an electronic sub-system, a pneumatic subsystem, and control software having a corresponding user interface. The electronic subsystem powers the solenoid pressure valve (fluidly connected to the balloon inflation port 22) under the control of the control software to control the pressurization/decompression cycles of operation of the balloon system of the present invention with airflow.

The inflation lumen 24 is configured to have and terminate therein a distal end of the interior 19 of the balloon 18 , preferably located near the proximal end 33 of the balloon. The inflation lumen 24 extends between the balloon inflation port 22 and the balloon 18 inside the elongate shaft 12 to provide a bidirectional passageway for fluid (air) to pressurize/depressurize the balloon 18 along it.

In the pressurized state, the balloon 18 assumes an expanded (inflated) state (shown in FIGS. 1 , 2, 3b - 3c, 4b, 4d, 5c, and 5f - 5g). On the other hand, in the decompressed state, the balloon 18 assumes a deflated (closed) state (shown in FIGS. 3A, 4A, 4C, 5B, 5D, 5E, 5H, 5i, and 5J).

The endovascular delivery system 1 of the present invention works in conjunction with a delivery component 31 , for example a guidewire. Guidewire 31 is advanced from the inside of the blood vessel toward (preferably beyond) the lesion site prior to cardiac (vascular) (or other intravascular) procedures. The endovascular transport system 1 is then moved to a location corresponding to the lesion site for pre-dilatation or other treatment along the guidewire 31 inside the blood vessel.

The fastenable balloon catheter 10 has a guidewire lumen 28 extending inside the elongated shaft 12 between a rapid-exchange (RX) port 30 and a tapered tip 32 . is configured to have The guidewire 31 extends distally within the guidewire lumen 28 beyond the tapered tapered end 32 .

Guidewire lumen 28 is sized to allow passage of guidewire 31 therethrough. For example, the guidewire lumen 28 may facilitate movement of the remote region 16 along the guidewire 31 to a desired location within the patient's vasculature or organ into which the guidewire is inserted. It can be of any size that allows it to be

As shown in FIG. 3C , the guidewire lumen 28 may be centered within the long axis 12 , or alternatively may be off-center. Preferably, the guidewire lumen 28 is compressible upon actuation of the balloon inflation system 25 by the operator, such as, for example, inflation of the balloon 18, so that the guidewire lumen 28 will be described in more detail below. 31) is signed there.

The long shaft 12 may preferably be constructed of a flexible material to facilitate compression of the guidewire lumen 28 . Elongated shaft 12 may be constructed of a flexible material over its entire length or over select portion(s) of its length, such as fasteners 17 inside balloon 18 .

In the system 1 of the present invention, a lockable balloon catheter 10 is supported by a balloon inflation system 25 and includes an inflation lumen 24 , a balloon 18 , and an engagement portion 17 of the long shaft 12 . ) and a locking mechanism for switching the system of the present invention between a locked mode of operation and an unlocked mode of operation.

In the fastening mode of operation, inflation of the balloon 18 is used to fasten the balloon catheter 10 to the guidewire 31 . For example, inflation of the balloon 18 to a predetermined pressure (eg, high pressure) may result in the engagement 17 of the long shaft 12 being guided (as shown in FIGS. 3B - 3C, 4B, and 4D). By causing the wire 31 to pressurize, the walls of the guidewire lumen 28 (extending from the RX port 30 to the balloon 18) compress the perimeter of the conveying guidewire 31, causing the guidewire ( 31) is fastened to the inside of the long shaft 12. In the compressed state, the tight fit between the walls of the guidewire lumen 28 and the guidewire 31 prevent relative movement between the guidewire 31 and the long axis 12 . As such, the close coupling between the guidewire 31 and the walls of the guidewire lumen 28 resulting from the controlled pressurization of the balloon 18 according to the needs of the treatment procedure is the guidewire 31 of the balloon catheter 10. It is fastened to the long shaft (12).

When the inflation system (25) of the fastening mechanism deflates the balloon, the walls of the guidewire lumen (28) return to their original state, thereby disengaging the guidewire from engagement with the elongated shaft (12). do. In the released state of operation, the guidewire and the constriction 12 are free to move relative to each other.

An RX (quick replacement) port 30 is formed on the long axis 12 a short distance from the proximal end 33 of the balloon 18 . This arrangement is such that the treatment instrument delivery catheter is transported along the guidewire 31 to the target site in the blood vessel while the balloon catheter 10 is fastened to the body cavity, as shown in FIGS. 5G-5J , and as will be described in more detail below. enables it to be

For example, while a typical quick change port is typically spaced at least 15 cm from the balloon, the RX port 30 of the inventive system 1 is much closer, eg, from the proximal end 33 of the inventive balloon. It is located about 1-5 mm to 30 mm.

The conciseness of the structure of the present invention has a beneficial result as the guidewire 31 emerges from the long axis 12 through the RX port 30 inside the blood vessel, where the balloon 10 is rigidly secured to the guidewire 31 within the body cavity. In a securely engaged state, the treatment instrument delivery catheter can be positioned near the RX port 30 and balloon 18 , providing stable conditions desirable for stent delivery. Accordingly, the treatment device delivery catheter is anchored and stabilized in the body cavity.

The balloon catheter 10 of the present invention may include one or more radiopaque markers to facilitate positioning of the balloon catheter 10 under fluoroscopic imaging. 1 , balloon catheter 10 includes radiopaque markers 34 , 36 , 38 , 40 , and 42 positioned along long axis 12 . These radiopaque markers may be made of a conventional material such as platinum or iridium. Radiopaque markers 34 and 36 are located at the distal end 37 and the proximal end 33 of the balloon 18, respectively, to visualize the position of the balloon 18 within the blood vessel. A radiopaque marker 38 is positioned adjacent to the RX port 30 to enable visualization of the location of the RX port 30 . The radiopaque markers 40 , 42 are axial markers and may each be spaced about 90-100 cm from the distal end (tip) 32 of the long axis 12 .

FIG. 2 shows another configuration of the endovascular delivery system of the present invention using the engageable balloon catheter 10 shown in FIG. 1 . The system includes a treatment device delivery catheter, one or more sheaths, and a delivery component. In the example shown in FIG. 2 , the system 50 includes a fastenable balloon catheter 10 , a sheath 52 , a sheath 54 , a transfer component (guidewire) 56 , and a treatment device transfer catheter. (60).

The sheath 52 is sized and shaped for an endovascular delivery procedure. The sheath 52 constitutes a lumen that allows the engageable balloon catheter 10 to be positioned therein for a transfer procedure.

The sheath 54 is sized and shaped for endovascular delivery and constitutes a lumen within which the therapeutic device delivery catheter 60 may be positioned for endovascular delivery. Coatings 52 and 54 may be conventional sheaths used in endovascular procedures.

The transfer component 56 has a size and shape suitable for an endovascular transfer procedure, and may be a guidewire as shown. In one example, transfer component 56 is a conventional guidewire used in endovascular procedures.

The treatment device delivery catheter 60 is designed to endovascularly deliver a treatment device (such as a stent) to a target site within a body cavity. This treatment instrument delivery catheter 60 includes an elongate axis 62 having a proximal area 64 and a remote area 66 . The balloon 68 is mounted on a remote area 66 of the long axis 62 .

The proximal area 64 of the long axis 62 is manipulated by the surgeon. For this purpose, the proximal end 64 has a handle 67 . The balloon inflation port 72 is connected to the interior 83 of the balloon 68 via an inflation lumen 75 extending therein along the long axis 62 .

A guidewire port 74 is connected to the distal end 66 of the long shaft 62 via a guidewire lumen 77 . The guidewire lumen 77 is sized to receive the guidewire 56 therein.

The handle 67 and ports 72, 74 are conventional members and, like the proximal end 64 of the treatment device delivery catheter 60, are commonly used in the manufacture of endovascular catheters, for example polyethylene or polyterephthalate. It may be made of a material that is Therapeutic delivery catheter 60 is preferably of a length and diameter suitable for use in therapeutic procedures involving cardiovascular or peripheral blood vessels.

The treatment device delivery catheter 60 is configured to deliver a treatment device 70 , which may be, for example, a stent. In the example shown in FIG. 2 , the treatment device delivery catheter 60 includes a balloon 68 positioned at a location in the remote region 66 of the long axis 62 inside the impingement device 70 . When the balloon 68 is inflated (as a result of the influx of fluid (or air) into the balloon inflation port 72 ), it means that the treatment device 70 is deployed (expanded) from the delivered (de-flated) state. ; expanded) to cause it to expand.

Although therapeutic device delivery catheter 60 is shown in this exemplary embodiment as a balloon catheter for stent delivery (eg, such as a bare metal stent or drug-eluting stent), therapeutic device delivery The catheter 60 may also deliver other types of therapeutic devices, such as a drug delivery catheter, a balloon catheter, a drug release balloon catheter, or an energy delivery catheter. Examples of delivered drugs include anti-mitotic drugs, regenerative agents, anti-inflammatory agents, anti-allergenic agents, anti-bacterial agents, Anti-viral agent, anticholinergic agent, antihistamine, antithrombotic agent, anti-scarring agent, antiproliferative agent, antihypertensive agent ( antihypertensive agent, anti-restenosis agent, healing promoting agent, vitamin, protein, gene, growth factor, cell, stem cell, vector ; DNA carrier), RNA, and/or DNA. Energy delivery catheters may contain various types of energy, including ultraviolet light, ultrasound, resistive heat, radio frequency (RF), and cryogenic.

3A, 3B, and 3C show one embodiment of a fastenable balloon catheter 10 of the present invention. 3a and 3b respectively While showing the balloon catheter 10 in the released state ( FIG. 3A ) and the engaged state ( FIG. 3B ), FIG. 3C shows a longitudinal section of the balloon catheter 10 of the present invention in the engaged state.

In FIG. 3A , the elongate catheter shaft 12 is in an unlocked state (mode of operation). In the released state, the diameter of the guidewire lumen 28 is sized to support sliding (displacement) of the guidewire 31 therein.

The long shaft 12 is formed by compressing the fastening portion 17 of the long shaft 12 inside the balloon 18 when the balloon 18 is inflated, thereby reducing the diameter of the guidewire lumen 28, thereby reducing the diameter of the long shaft 12. ) is converted to the fastening state shown in FIGS. 3b - 3c as the walls of the fastening portion 17 wrap around the guide wire 31 and press the guide wire 31 into the guide wire lumen 28 . For example, introducing fluid (air) into balloon 18 through inflation lumen 24 and balloon inflation port 16 , balloon 18 inflates and confines interior space 19 of balloon 18 . As shown in 3b and 3c, the walls of the fastening portion 17 of the long shaft 12 are pressed to the level of compression. Preferably, inflation of the balloon 18 not only couples the guidewire lumen 28 to the guidewire 31, but also the engagement of the walls of the balloon 18 with the inner lining of the body cavity 100 as well. By improving, the balloon 18 is anchored inside the body cavity to stabilize the fastened guide wire 31 in the body cavity 100 as shown in FIGS. 3A-3B .

4A and 4B show the remote area of a catheter 10' similar to that shown in FIGS. 3A, 3B, and 3C. The catheter 10' includes a flexible material 44 to facilitate the fastening mechanism to the fastening portion 17' of the elongated shaft 12' inside the balloon 18'. Since the fastenable balloon catheter 10 ′ is manufactured in a configuration similar to that of the fastenable balloon catheter 10 shown in FIGS. 1 - 2 and 3a - 3c , similar members are indicated by attaching a prime (') to a similar number. The flexible material 44 may extend only within the balloon 18' (only the fastener 17') along the long axis 12' or further along the entire length of the long axis 12'. The flexible material 44 may be made of, for example, a knitted material such as a braided metal such as stainless steel. The knitted material may be coated with another fluid impermeable material, such as a polymer. As shown, the flexible material 44 of the fastening portion 17' is configured to be compressed when, for example, inflation and pressurization of the balloon 18 is actuated, thereby fastening the guidewire lumen to the transfer component 56'.

4C-4D, the inventive balloon catheter 10" may be reinforced with a kink resistant mechanism 120. The RX port 30 and balloon 18 of the inventive system ) of the liver, potentially sharp twisting, kinking (sharp) on the long catheter shaft 12 as the inflated balloon 18 is pulled along the guidewire as another delivery device (stent) is advanced on the guidewire. buckling), and/or a part prone to curving.

To prevent unwanted deviation of the elongate catheter shaft 12 from its straight state during cardiovascular procedures, an alternate embodiment of the inventive system 10" is configured with an anti-distortion mechanism 120. Anti-distortion mechanism 120 is an internally attached Nitinol/Steel wire-like member between the RX port 30 and the balloon 18 along the long catheter axis 12 (as shown in FIG. 4C ). ) (or stamped elongate member) 122. Alternatively, the anti-warpage mechanism 120 is an elongate portion connected (preferably integral thereto) via a central circular (or oval) shaped portion 128 . An elongated member 124 of nitinol/steel configured to have 126. The elongated member 124 may be embedded in the wall of the elongated catheter shaft 12, and also the central portion 128 It may be attached along the inside or outside of the elongate catheter shaft 12 (as shown in FIG. 4D ) while being aligned with the outer periphery of the RX port 30 and secured to the RX port 30 .

Alternatively, the anti-distortion mechanism 120 may be embedded in the wall of the long catheter shaft 12 between the RX port 30 and the balloon 18 or fixed to (inside or outside of) the wall of the long catheter shaft 12 . It can also be implemented with two members 122 and 124 (combined embodiment).

Whether embedded, internally or externally secured, or in any combination of embodiments, the anti-twist mechanism 120 prevents abrupt twisting, bending, and curling of the elongated catheter shaft 12, making it suitable for various scenarios of cardiovascular procedures. A robust system capable of responding is provided.

While what is shown in Figures 4c - 4d applies to the embodiment shown in Figures 4a - 4b, the anti-distortion mechanism 120 may be applied to all alternative embodiments of the inventive system shown in Figures 1 - 5i. have.

The method of the present invention may use a balloon catheter (10, 10') that can be tightened to perform an interventional procedure. However, by way of example only, the method of the present invention is described below ( infra ) for use with the engageable balloon catheter 10 shown in FIGS. 1 , 2 and 3A - 3C . The alternative catheter 10' shown in FIGS. 4A-4B may also be used in a similar manner as described below.

In Fig. 5A, the transfer part (guide wire) advances inside the blood vessel and is transferred to the target position. In this example, a transfer component 56 (eg a guidewire) is positioned at the location of the lesion L in the vessel V as determined by fluoroscopic imaging techniques, contrast agents, and/or conventional interventional techniques. .

As shown in FIG. 5B , the balloon catheter 10 connects the proximal end 80 of the guidewire 56 to the remote end of the guidewire lumen 28 located at the distal tip 32 of the balloon catheter 10 . The balloon catheter 10 is backloaded onto the transfer component 56 by insertion into the distal end 82 . The catheter 10 is positioned on the patient's vasculature until the remote area 16 is positioned at a target location (e.g., lesion L) determined using fluoroscopy imaging with radiopaque markers on catheter axis 12. advancing through blood vessels; V). When positioned within the patient's blood vessel V, the remote region 16 of the balloon catheter 10 will appear as shown in FIG. 5B . During the transfer procedure, the balloon 18 of the catheter 10 may be wrapped or folded in a closed state.

Alternatively, a transfer sheath (such as sheath 52 shown in FIG. 2 ) may be positioned on the remote area 16 of the balloon catheter 10 to achieve a smooth outer surface of the engageable balloon catheter 10 . After reaching the desired position L in the vessel V, the sheath 52 may be withdrawn proximally to expose the remote area 16 . As shown, guidewire 56 is positioned within guidewire lumen 28 inside balloon 18 and exits catheter 10 at guidewire RX port 30 .

Referring now to FIGS. 5C and 1 , a conventional inflation system 25 is connected to the inflation port 22 to provide an inflation medium 27 such as, for example, saline or saline dilute iodine-based contrast agent. This inflation lumen 24 is transported to the balloon 18 to cause inflation of the balloon. In the inflated state, the wall of the balloon 18 contacts the lesion L and the intima of the blood vessel V to dilate the blood vessel V and disrupt the lesion L. The balloon 18 is then deflated as shown in FIG. 5D .

In FIG. 5E , the balloon 18 in the deflated state is advanced along the distal end 86 of the guidewire 56 to a position near but past the target site L inside the body cavity V. For example, the engageable balloon catheter 10 and transfer part 56 move distally inside the vessel V so that the RX port 30 is distal to the target site L. and the proximal end 80 of the transfer component (guidewire) 56 may be located outside the catheter 10 and extend through the target site inside the body cavity V.

The balloon catheter 10 is then fastened to the transfer component 56 by introducing fluid 27 into the balloon 18 through the inflation lumen 24 and balloon inflation port 26 as shown in FIG. 5F . The introduction of the fluid 27 under high pressure causes the balloon 18 to inflate and the inner space 29 of the balloon 18 compresses the long catheter shaft 12 so that the guidewire lumen 28 is accommodated in the transfer part ( The transfer component 56 is fastened to the elongate shaft 12 by compressing it around the transfer component 56 by pressing it to a level that will force it to adhere to the long shaft. In addition, the inflation of the balloon 18 anchors the balloon 18 to the inside of the blood vessel with or without close contact with the lining of the blood vessel V, thereby stabilizing the fastened transfer part 56 inside the blood vessel V .

As represented in FIG. 5G , balloon catheter 10 is fastened to delivery component 56 and delivery component 56 (with or without contact of balloon 18 wall 84 with vessel V intima) Once secured in place within the body cavity, the treatment device transfer catheter 60 is transferred along the transfer component 56 to align the treatment instrument 70 with the target site L. During transfer, the balloon 68 of the treatment device transfer catheter 60 may be in a collapsed state. Alternatively, a transfer sheath (such as sheath 54 shown in FIG. 2 ) may be positioned over remote area 66 of catheter 60 to form a smooth outer surface of treatment device delivery catheter 60 . After reaching the desired location in vessel V, sheath 54 is withdrawn proximal to expose remote area 66. In the body cavity (V), both use the same delivery component (56), but the engageable balloon catheter (10) remains separate from the treatment instrument delivery catheter (60).

The engageable balloon catheter 10 is then released from the transfer component 56 , as shown in FIG. 5H . For example, when the balloon 18 is deflated, the long axis 12 is decompressed to expand the diameter of the guide wire lumen 29 in the fastening portion 17, and the guide wire 56 therein. allow sliding movement of

As shown in FIG. 5I , the transfer part (guidewire) 56 is then disconnected from the engageable balloon catheter 10 . For example, while the engageable balloon catheter 10 is held in place, the transfer part 56 may be pulled proximally until the distal end 86 of the transfer part 56 exits the RX port 30 . have. Alternatively, the engageable balloon catheter 10 may move distally while the transfer component 56 remains in place until the distal end 86 of the transfer component 56 exits the RX port 30 . .

Then, as shown in Figure 5j, while the treatment device delivery catheter 60 is positioned at the target site (L) inside the blood vessel (V), the fastening balloon catheter 10 passes the target site (L) to the proximal side. Move. The engageable balloon catheter 10 may be completely removed from the patient's blood vessel (V) or moved to an appropriate proximity to allow for treatment device placement. Alternatively, the balloon catheter may move to another vessel or branch of the vessel (V).

Then, as shown in FIG. 5K , a treatment device (stent) 70 is placed on the target site L. For example, the balloon is inflated and expanded so that the treatment device 70 is inflated to contact the inner wall of the blood vessel (V).

Subsequently, as shown in FIG. 5L , when the treatment device (stent) 70 is designed for implantation, the treatment device delivery catheter 60 is removed, leaving the treatment device 7 embedded in the target position L. do.

Although the present invention has been described in connection with specific forms and embodiments thereof, it should be understood that various modifications other than those described above are possible without departing from the spirit and scope of the present invention as defined in the appended claims. For example, functionally equivalent elements may be substituted for those specifically shown and described, some features may be used independently of other features, all without departing from the spirit and scope of the invention as defined in the appended claims; In some cases, the positions, steps, or processes of certain elements may be reversed or overlapped.

Claims (21)

An endovascular delivery system for reliably advancing a stent along a guidewire to a lesion site inside a patient's blood vessel, the system comprising:
an elongate catheter shaft having a proximal region, a remote region, and a quick change (RX) port formed between the proximal and remote regions of the walls of the elongate catheter shaft;
an inflation lumen extending between the proximal region and the remote region within the elongate catheter shaft;
A guidewire lumen extending distally from the RX port toward and along the remote area within the elongate catheter shaft.
At least one fastenable balloon catheter comprising;
Having a proximal end and a remote end, the balloon being fixed to the remote area on the long catheter side, the proximal end being spaced apart from the RX port by a predetermined distance; and
a fastening mechanism operatively coupled between the balloon and the elongate catheter shaft, wherein the fastening mechanism engages the elongate catheter axis in an unlocked state wherein a diameter of the guidewire lumen permits sliding of the guidewire therein; The walls of the long catheter shaft are compressed by the pressure inside the balloon as a result of the expansion of the balloon, thereby reducing the diameter of the guidewire lumen, thereby contacting the circumference of the guidewire and preventing movement of the guidewire in the guidewire lumen in a closed state the fastening mechanism configured to switch between;
An endovascular delivery system provided with. According to claim 1,
wherein the inflation lumen is configured to terminate therein with a balloon inflation port located proximate the proximal end of the interior of the balloon, wherein the fastening mechanism comprises the balloon, the walls of the elongate catheter shaft, the inflation lumen and the elongate catheter shaft. a balloon inflation system operatively connected to the inflation lumen at the proximal end, wherein the balloon inflation system is controlled to inflate and deflate the balloon through the inflation lumen and the balloon inflation port formed therein; The inflated intravascular delivery system converts the engageable balloon catheter to the engaged state, and the balloon deflates to convert the engageable balloon catheter to the unlocked state. 3. The method of claim 2,
In the engaged state of the engageable balloon catheter, the balloon assumes an inflated state, and in the inflated state the fastening mechanism is further brought into contact between the walls of the balloon between the proximal and distal ends of the balloon and the inner wall of the blood vessel. Reinforced endovascular delivery system. According to claim 1,
wherein the elongated catheter shaft has a flexible material positioned between the proximal and distal ends of the balloon to facilitate compression on at least a portion of the walls of the elongated catheter shaft. 5. The method of claim 4,
wherein the flexible material comprises a knitted material, the knitted material comprises a metal, and the knitted material is coated with a polymer such that the portion of the long catheter axis between the proximal and distal ends of the balloon is fluid impermeable. transport system. According to claim 1,
and an anti-distortion mechanism attached to the elongate catheter shaft and extending along it between the RX port and the proximal end of the balloon, wherein the anti-distortion mechanism is embedded in the wall of the elongate catheter shaft external to the guidewire lumen or An endovascular delivery system comprising an elongated reinforcing structure secured within or outside thereof. According to claim 1,
and a plurality of radiopaque markers positioned along the elongate catheter axis. 8. The method of claim 7,
wherein a radiopaque marker of a plurality of radiopaque markers is positioned adjacent the RX port. According to claim 1,
An endovascular delivery system in which the distance between the RX port and the proximal end of the balloon is in the range of 1 mm to 30 mm. An endovascular delivery system for reliably advancing a therapeutic device along a delivery component to a target site within a body cavity of a patient, the system comprising:
an elongate catheter shaft having a proximal region, a remote region, and a quick change (RX) port formed between the proximal and remote regions of the walls of the elongate catheter shaft;
an inflation lumen extending between the proximal region and the remote region within the elongate catheter axis;
a transfer part lumen extending distally from the RX port toward and along the remote area within the elongate catheter shaft.
A fastenable balloon catheter comprising;
A balloon having a proximal end and a remote end and fixed to the remote region on the long catheter side, wherein the proximal end of the balloon is spaced apart from the RX port by a predetermined distance;
a fastening mechanism operatively coupled between the balloon and the elongate catheter shaft, wherein the fastening mechanism engages the elongate catheter axis in an unlocked state wherein a diameter of the transfer part lumen permits sliding of the transfer part therein; the walls of the elongate catheter shaft are compressed by the pressure inside the balloon to reduce the diameter of the conveying part lumen by contacting around the conveying part and preventing movement of the conveying part within the guidewire lumen as the walls of the long catheter shaft are in a closed state the fastening mechanism configured to switch between; and
a treatment device delivery catheter for conveying a treatment device to its remote end and operatively coupled to the delivery part to move along the delivery part to a target position within the body cavity;
With the balloon inflated and anchored within the body cavity, the treatment device is advanced along the conveying component to a target site within the body cavity near the RX port. 11. The method of claim 10,
wherein the transfer component is a guidewire. 11. The method of claim 10,
wherein the treatment device is a stent. 11. The method of claim 10,
The long catheter shaft is made of a flexible material inside the balloon to facilitate compression of the walls of the catheter shaft. 14. The method of claim 13,
Intravascular delivery system wherein the flexible material comprises a knitted material. A method for reliably advancing a treatment device along a guide wire to a lesion site inside a patient's blood vessel, the method comprising:
an elongate catheter shaft having a proximal region, a remote region, and a quick change (RX) port formed between the proximal and remote regions of the walls of the elongate catheter shaft;
an inflation lumen extending between the proximal region and the remote region within the elongate catheter axis;
A guidewire lumen extending distally from the RX port toward and along the remote area within the elongate catheter shaft.
A fastenable balloon catheter comprising;
A balloon having a proximal end and a remote end and fixed to the remote region on the long catheter side, wherein the proximal end of the balloon is spaced apart from the RX port by a predetermined distance; and
a fastening mechanism operatively coupled between the balloon and the elongate catheter shaft, wherein the fastening mechanism engages the elongate catheter axis in an unlocked state wherein a diameter of the guidewire lumen permits sliding of the guidewire therein; The walls of the long catheter shaft are compressed by the pressure inside the balloon as a result of the expansion of the balloon, thereby reducing the diameter of the guidewire lumen, thereby contacting the circumference of the guidewire and preventing movement of the guidewire in the guidewire lumen in a closed state the fastening mechanism configured to switch between
constructing;
transferring the fastenable balloon catheter to the lesion site inside the blood vessel on the guide wire;
expanding the blood vessel and destroying the lesion by inflating the balloon of the fastenable balloon catheter;
deflating the balloon and moving the balloon near the lesion site inside the blood vessel;
fastening the balloon catheter to the guide wire by re-inflating the balloon; and
transferring the second catheter to the lesion site on the guide wire
A method for intravascular transport of a therapeutic device provided with. 16. The method of claim 15,
wherein the second catheter comprises a stent, the method comprising:
transferring the stent to the lesion site inside the blood vessel
Intravascular delivery method of the treatment device further comprising. 17. The method of claim 16,
prior to transferring the stent, removing the engageable balloon catheter from the vessel
Intravascular delivery method of the treatment device further comprising. 16. The method of claim 15,
While the balloon catheter maintains the fastening to the guide wire and the guide wire is fixed and stabilized in the blood vessel inside the fastenable balloon catheter, the second catheter is transferred intravascular transport method of the treatment device . 16. The method of claim 15,
The fastening step of the fastenable balloon catheter to the guidewide intravascular delivery method of the treatment device comprising the step of expanding the balloon. 20. The method of claim 19,
wherein inflation of the balloon causes the walls of the guidewire lumen inside the balloon to be compressed around the guidewire. An endovascular delivery system for reliably advancing a stent along a guidewire to a lesion site within an internal passageway within a patient's body, the internal passageway comprising at least one of a blood vessel, a bile duct, and a ureter, the system comprising:
an elongate catheter shaft having a proximal region, a remote region, and a quick change (RX) port formed between the proximal and remote regions of the walls of the elongate catheter shaft;
an inflation lumen extending between the proximal region and the remote region within the elongate catheter axis;
A guidewire lumen extending distally from the RX port toward and along the remote area within the elongate catheter shaft.
A fastenable balloon catheter comprising;
A balloon having a proximal end and a remote end and fixed to the remote region on the long catheter side, wherein the proximal end of the balloon is spaced apart from the RX port by a predetermined distance; and
a fastening mechanism operatively coupled between the balloon and the elongate catheter shaft, wherein the fastening mechanism engages the elongate catheter axis in an unlocked state wherein a diameter of the guidewire lumen permits sliding of the guidewire therein; The walls of the long catheter shaft are compressed by the pressure inside the balloon as a result of the expansion of the balloon, thereby reducing the diameter of the guidewire lumen, thereby contacting the circumference of the guidewire and preventing movement of the guidewire in the guidewire lumen in a closed state the fastening mechanism configured to switch between
Conveying system provided.

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